Skip to main content
Clinical Trials/NCT03489577
NCT03489577
Terminated
Not Applicable

The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients

UMC Utrecht1 site in 1 country15 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Trauma
Sponsor
UMC Utrecht
Enrollment
15
Locations
1
Primary Endpoint
Bactericidal capacity of neutrophils and sepsis
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

Patients admitted to the Intensive Care Unit after severe injury are prone to suffer from infectious complications and even sepsis. Despite tremendous efforts the etiology of this increased susceptibility to infectious pathogens is incompletely understood. Clinical signs and symptoms as well as current diagnostic clinical tests (WBC, CRP, cytokines, interleukines) lack sensitivity or specificity for adequate prediction of the development of infectious complications or sepsis.

Neutrophil granulocytes, cells of the innate immune system, play an important role in the defence against invading bacterial pathogens and are crucial in preventing fulminant infections. For successful eradication of a bacterium neutrophils need to exert specific functions: chemotaxis, migration, phagocytosis, degranulation and production of radical oxygen species. Much research has focused on the effect of trauma on neutrophil's individual capacities to kill bacteria with conflicting interpretations as a result. For adequate determination of the neutrophil's capacity to eradicate bacteria from tissue of trauma patients we developed novel in-vitro assays in which neutrophils are tested for all of these functions combined. This assay allows us to identify dysfunctional neutrophils adequately.

The main focus of this study is the determination of the functionality of aberrant neutrophils circulating in the peripheral blood of severly injured following trauma.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
June 1, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. dr Leenen

Prof. Dr.

UMC Utrecht

Eligibility Criteria

Inclusion Criteria

  • Admitted to the ICU
  • Expected stay of at least 2 days
  • Age: 18 - 80 years
  • Informed consent (when proxy consent is obtained and the patient leaves the ICU in good mental health, personal informed consent is additionally necessary)

Exclusion Criteria

  • Immunosuppressive medication
  • HIV and related diseases

Outcomes

Primary Outcomes

Bactericidal capacity of neutrophils and sepsis

Time Frame: 15 days following admission on ICU

The correlation between reduced bactericidal capacity of neutrophils acquired from severely injured patients and the late occurrence of sepsis

Secondary Outcomes

  • Bactericidal capacity of neutrophils and pro-inflammatory complications(15 days following admission to the ICU)
  • Bactericidal capacity of neutrophils and infectious complications(15 days following admission to the ICU)
  • T-cell proliferation and infectious complications(15 days following admission on ICU)
  • Priming capacity of neutrophils and infectious complications(15 days following admission on the ICU)
  • Complement system and infectious complications(15 days following admission to the ICU)

Study Sites (1)

Loading locations...

Similar Trials